The efficacy and safety of Codonopsis lanceolata water extract for sarcopenia: A study protocol for randomized, double-blind, placebo-controlled clinical trial.

Introduction: This study aimed to propose a protocol to demonstrate the efficacy of Codonopsis lanceolata water extract for the improvement of skeletal muscle mass (SMM) and function (muscle strength or performance function) and its safety compared to a placebo in adults with reduced muscle strength.

Methods And Analysis: A randomized double-blind placebo-controlled clinical trial was conducted. Participants will be recruited from the Korean Medicine Hospital in South Korea. One hundred and four adults with reduced muscle strength will be randomly assigned a 1:1 ratio to either the experimental or placebo comparator groups. The participants will consume the product corresponding to their assigned group for the following 12 weeks, and efficacy and safety tests will be conducted. This is the first clinical trial of C lanceolata water extract in adults with reduced muscle strength. The results of this study would provide a clinical basis for the efficacy and safety of C lanceolata water extract in patients with sarcopenia.

Ethics And Dissemination: This trial was approved by the Institutional Review Board (IRB) of Kyung Hee University Korean Medicine Hospital at Gangdong on July 15, 2021 (amendment number: MLB_DDE_H01 [ver. 01]). When a change was made in the clinical trial plan, the IRB reviewed and approved the revised clinical trial plan. The study was registered on the Clinical Research Information Service website on December 3, 2021 (registration number: PRE20211203-003; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=20841&status=1&seq_group=20841&search_page=M). The results of this clinical trial will be reported in the future. Every document related to the clinical trial, such as the electronic case report form, will be recorded and classified by the subject identification code and not by the subject name.